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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02001116
Other study ID # WHOCCT-001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 27, 2013
Last updated August 24, 2015
Start date October 2013
Est. completion date December 2014

Study information

Verified date August 2015
Source WHO Collaborating Centre for Maternal and Child Health, Trieste
Contact n/a
Is FDA regulated No
Health authority Italy: Institutional Review BoardKyrgyz Republic: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A cooperation agreement between the Ministry of Health (MOH) of Kyrgyz Republic and WHO-EURO was established, for the implementation of a WHO Project to improve the quality of pediatric care in the referral hospitals. The pilot regions selected for this intervention are the three northern regions of Thalas, Chiu and Issik-Kul Region in Kyrgyz Republic. The MOH project will be implemented at a first stage in a group of 10 pilot hospitals, randomly selected among the existing hospitals in the above cited regions. Pilot Hospitals will be compared to "control hospitals", which are the hospitals in the region not receiving the intervention, using a pre-defined set of indicators of quality of care. The results of the present evaluation on the pilot hospitals will provide data that will inform the MOH on how better to scale up this project at a national scale.


Recruitment information / eligibility

Status Completed
Enrollment 4626
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 59 Months
Eligibility Inclusion Criteria:

- The study will evaluate Quality of Care delivered to children at hospital level. This will be assessed by a direct review of patients' charts, in comparison with pre-defined standard. At the hospital level children's charts will be randomly chosen among children 2 months to 59 months, hospitalized with common diseases, such as acute respiratory diseases, diarrhoea, and fever.

Exclusion Criteria:

- Children not included in the above criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms

  • Quality of Hospital Care for Children

Intervention

Other:
Quality Improvement intervention
Training for local trainers and medical staff on the National Adaptation of the WHO guidelines "Pocket Book of Hospital Care for Children". Regular supporting supervision and monitoring at hospital level aimed at a sustainable improvement of the quality of the paediatric hospital care

Locations

Country Name City State
Kyrgyzstan Thalas, Chiu and Issik-Kul Regions Thalas, Chiu, Issik-Kul

Sponsors (4)

Lead Sponsor Collaborator
WHO Collaborating Centre for Maternal and Child Health, Trieste Postgraduate Institute of Medical Education and Research, Scientific Center of Children RAMS, World Health Organization

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Care Quality of Care will be measured using 10 pre-defined indicators
Inappropriate hospitalisation (i.e. versus WHO standards)
Increased risk of iatrogenic adverse effects (i.e unnecessary poly-therapy, compared to WHO standards)
Unnecessary pain (i.e. unnecessary injections or other invasive procedures, as compared to WHO standards)
Incorrect Diagnosis (i.e. versus WHO standards)
Incorrect Treatment (i.e. versus WHO standards)
Inconsistency between diagnosis and treatment (i.e. versus WHO standards)
Inadequate Monitoring: (i.e. versus WHO standards)
Lack of nutritional evaluation (i.e. versus WHO standards)
Incorrect use of IV fluids (i.e. versus WHO standards)
12 months Yes
Primary Primary outcome Children with concomitant presence of all the following three indicators of case management: 1) unnecessary hospitalization; 2) increased risk of iatrogenic adverse effects; 3) unnecessary painful procedures 12 months Yes
Secondary Outcomes of QoC Summary scores according to the WHO Quality Asessment Tool 12 months Yes